Int.J. Behav. Med.

(2013) 20:385396
DOI 10.1007/s12529-012-9241-6

Mindfulness-Based Stress Reduction for the Treatment

of Irritable Bowel Syndrome Symptoms: A Randomized
Wait-list Controlled Trial
Kristin A. Zernicke & Tavis S. Campbell &
Philip K. Blustein & Tak S. Fung & Jillian A. Johnson &
Simon L. Bacon & Linda E. Carlson

Published online: 23 May 2012

# International Society of Behavioral Medicine 2012

Abstract program (n043) or to wait for the next available program

Background Irritable bowel syndrome (IBS) is a functional (n047). Patients completed IBS symptom severity, stress,
disorder of the lower gastrointestinal (GI) tract affected by mood, quality of life (QOL), and spirituality scales pre- and
stress, which may benefit from a biopsychosocial treatment post-intervention or waiting period and at 6-month follow-up.
approach such as mindfulness-based stress reduction (MBSR). Intent-to-treat linear mixed model analyses for repeated meas-
Purpose A treatment as usual (TAU) wait-list controlled ures were conducted, followed by completers analyses.
trial was conducted in Calgary, Canada to investigate the Results While both groups exhibited a decrease in IBS symp-
impact of MBSR on IBS symptoms. It was hypothesized tom severity scores over time, the improvement in the MBSR
that MBSR patients would experience greater reduction in group was greater than the controls and was clinically mean-
overall IBS symptom severity and self-reported symptoms ingful, with symptom severity decreasing from constantly to
of stress relative to control patients. occasionally present. Pre- to post-intervention dropout rates of
Method Ninety patients diagnosed with IBS using the Rome 44 and 23 % for the MBSR and control groups, respectively,
III criteria were randomized to either an immediate MBSR were observed. At 6-month follow-up, the MBSR group main-
tained a clinically meaningful improvement in overall IBS
K. A. Zernicke : T. S. Campbell : J. A. Johnson : L. E. Carlson
symptoms compared to the wait-list group, who also improved
Department of Psychology, University of Calgary, marginally, resulting in no statistically significant differences
Calgary, Alberta, Canada between groups at follow-up. Improvements in overall mood,
QOL, and spirituality were observed for both groups over time.
P. K. Blustein
Department of Medicine, University of Calgary,
Conclusions The results of this trial provide preliminary ev-
Calgary, Alberta, Canada idence for the feasibility and efficacy of a mindfulness inter-
vention for the reduction of IBS symptom severity and
T. S. Fung symptoms of stress and the maintenance of these improve-
Information Technologies, University of Calgary,
Calgary, Alberta, Canada
ments at 6 months post-intervention. Attention and self-
monitoring and/or anticipation of MBSR participation may
S. L. Bacon account for smaller improvements observed in TAU patients.
Department of Exercise Science, Concordia University,
Montral, Quebec, Canada
Keywords Mindfulness-based stress reduction . Irritable
L. E. Carlson bowel syndrome . Stress . Mood . Meditation . Yoga
Department of Oncology, University of Calgary,
Calgary, Alberta, Canada

L. E. Carlson (*) Introduction

Department of Psychosocial Resources, University of Calgary,
2202 2nd Street SW,
Calgary, Alberta T2S 3C1, Canada Irritable bowel syndrome (IBS) is a functional disorder of
e-mail: [email protected] the lower gastrointestinal (GI) tract defined by the presence
386 Int.J. Behav. Med. (2013) 20:385396

of chronic or recurring symptoms that include abdominal pain, Mindfulness-Based Stress Reduction
flatulence, bloating, and altered bowel habits [1]. IBS is clas-
sified as a functional GI disorder, and hence, there are no MBSR is a group psychosocial intervention, incorporating a
known biochemical, structural, or physiological abnormalities biopsychosocial orientation, consisting of mindfulness med-
that consistently characterize it. Often, a diagnosis of IBS is itation practice and gentle hatha yoga stretches that has been
made when other GI diseases, including inflammatory bowel applied within chronically ill populations, with one goal of
disease (e.g., Crohns disease or ulcerative colitis), lactose or reducing stress and disease symptoms [27]. MBSR has its
gluten intolerance, and intestinal parasites have been ruled out roots in contemplative spiritual traditions in which mindful-
[2]. The prevalence of IBS in Western populations is estimated ness, the cultivation of conscious awareness in the present
to be between 5 and 20 % [36] and it affects approximately moment in an open and nonjudgmental manner, is actively
12 % of Canadian adults (2.8 million) [7]. IBS accounts for practiced [27]. The application of mindfulness-based
3050 % of referrals to GI specialists [8, 9] and tends to follow concepts and techniques is intended to target unhelpful
a chronic relapsing and remitting course [10, 11]. psychosocial processes such as rumination, worry, and poor
A theory proposed by Burnett and Drossman suggests emotion regulation, potentially leading to improved symp-
that chronic GI symptoms are generated by a combination of toms, physiological processes, and quality of life (QOL)
intestinal, motor, sensory, and central nervous system activity [28, 29]. MBSR intends to cultivate the ability to develop
termed the braingut axis [12]. The mechanism for these actively sustained attention to mental content, which may
associations provides a bidirectional relation between sensa- gradually give rise during nonevaluative observation to a
tion in the intestines and intestinal motor function [1214]. greater understanding of perceptions, creating a more accu-
Cognitive information and external stressors have, through rate representation of ones own mental responses to exter-
neural connections, the ability to affect GI sensation, motility, nal and internal stimuli. This awareness may facilitate
and secretion [15]. Increased muscle contractions and pain can enhanced emotional processing and coping regarding the
also increase psychological distress through amplified cogni- effects of chronic illness and stress and improved self-
tive interpretations of these sensations [12]. efficacy and sense of control [27, 30].
The physiology of the digestive tract, as well as the
subjective experience of symptoms, health behaviors, and Mindfulness-Based Stress Reduction for IBS
treatment outcomes, is affected by stress [1618]. Stress
and emotions may trigger neuroimmune/neuroendocrine Meditation programs specifically for the treatment of IBS
reactions via the braingut axis, subsequently influencing symptoms are gaining research attention. It is hypothesized
GI, endocrine, and immune function [18, 19]. In both that the practice of meditation and ancillary techniques
retrospective and prospective studies, chronic stress could help patients diagnosed with IBS cope with their
[2023], acute stress [24, 25], and increased stress percep- disease by providing a means of monitoring and regulating
tion have been shown to exacerbate IBS symptomatology their own arousal, allowing them to gain awareness and
[23]. Given the increased stress response associated with evaluate problems with greater emotional stability and by
viscerally related events, poor or inappropriate coping providing an active role in pursuing personal health goals
responses to GI-related events, psychosocial adjustment to [28]. The focused attention characteristic of mindfulness
illness, and limited success of current medical treatments, meditation may enhance a sense of participatory agency
psychological treatments have been investigated to address during the program and may result in the reduction of
symptoms of IBS. stress-related emotional and cognitive factors contributing
Psychological treatments, such as cognitive behavioral to the exacerbation of IBS symptoms.
therapy and hypnosis, have shown promising results, point- Kearney et al. [31] conducted a prospective nonrandom-
ing toward the need to incorporate the biopsychosocial ized trial investigating an MBSR program for 93 patients
perspective into the treatment of IBS symptoms [11]. diagnosed with IBS using the Rome III criteria. Assessment
Preliminary evidence supports cognitive behavioral therapy, measures at 2- and 6-month follow-up revealed that partic-
dynamic psychotherapy, and hypnotherapy as having thera- ipation in the MBSR program was associated with improve-
peutic benefits such as global IBS symptom and abdominal ment in IBS-related QOL and GI-specific anxiety, but not
pain reduction greater than usual care; however, only a with IBS-specific symptom severity [31]. Due to the prom-
subset of patients respond and the potential mechanisms ising results, the authors called for randomized controlled
for such psychological therapies are not fully understood trials to investigate the role of MBSR for IBS symptom
[26]. Therefore, alternative psychological therapies for IBS severity. Gaylord and colleagues subsequently randomized
warrant investigation, and mindfulness-based stress reduc- 75 women to one of two 8-week group interventions (mind-
tion (MBSR) could, through hypothesized mechanisms, be fulness or social support) and reported clinically significant
an alternative treatment for this specific population. reductions in IBS symptom severity for the mindfulness
Int.J. Behav. Med. (2013) 20:385396 387

group following the intervention and at 3-month follow-up assessed during the first data collection session using a
compared to the social support group [32]. No significant medical history questionnaire designed for this study and,
differences were reported between the two groups for if required, followed up for diagnostic clarity by the clinical
psychological distress, QOL, or visceral anxiety immediately psychologist principal investigator (LEC).
post-intervention; however, the mindfulness group showed During screening, patients were asked to self-report
significant improvements in these measures at 3-month whether they had recently started or changed any medica-
follow-up compared to the support condition [32]. tions within the last 3 months. In order to ensure stability
The present investigation furthers the literature by inves- of medication over the course of the study, if there had
tigating the efficacy of an MBSR program in reducing been a change in medication, patients were asked to wait
symptoms of stress and improving psychological well- 3 months before being enrolled in the next cohort for
being as well as IBS symptoms in a sample of men and randomization and not to change regimens or dosages for
women who met the Rome III criteria, both immediately the duration of the study. Prior to the intervention, patients
following the intervention and at 6-month follow-up. Given completed informed consent, and baseline study measures
the chronic and fluctuating course of IBS, a 6-month follow-up were obtained. Consenting patients were randomized to
period seems warranted to better investigate the longer-term either the immediate MBSR intervention or to the TAU
effects of an MBSR program. Specifically, the present investi- control group, which received the MBSR program after the
gation utilized a randomized treatment as usual (TAU) 6-month follow-up period. Randomization was completed
waitlist controlled trial design to examine the impact of an 8- with a computer-based two-digit random number genera-
week MBSR program on the physical symptoms of IBS and tion program.
stress symptoms, as well as several psychological aspects of
well-being including QOL, mood, and spirituality immediately Psychological Questionnaire Measures
after the program and 6 months later. It was hypothesized that
patients who participated in the MBSR program would experi- Demographic and Medical History Questionnaires
ence: (1) greater reductions in IBS symptom severity; (2)
greater reduction in non-GI symptoms of stress and mood A demographic questionnaire assessing age, sex, socioeco-
disturbance and improved QOL compared to a TAU wait-list nomic status (years of education), and education was ad-
control; and that (3) reduction in symptoms would be main- ministered, as well as a questionnaire assessing medical
tained at the 6-month follow-up. history, psychiatric history, and current medications.

Health Behaviors Forms

Methods
A retrospective self-report questionnaire was administered
Sample to assess frequency of alcohol, nicotine, and caffeine
consumption (per day, week, or month). Sleep amount and
Ethics approval was obtained from the Office of Medical quality (poor, fair, or good), physical activity, and diet (poor,
Bioethics, Faculty of Medicine, University of Calgary. Men fair, or good) were also assessed. These behaviors have been
and women who received a diagnosis of IBS by a gastroen- identified as triggers for IBS symptoms [33].
terologist in Calgary, Alberta, Canada were identified
through medical chart review and recruited from multiple Meditation Practice
gastroenterologists offices from summer 2007 to fall 2010
via invitation phone calls. In addition, gastroenterologists A weekly practice log was included in the MBSR patient
within the community were provided with pamphlets and booklet. Patients recorded the total minutes spent daily
posters to refer newly diagnosed and existing patients to the meditating and practicing the skills learned in the classes
study. Self-referred patients were first screened by a gastro- throughout the MBSR intervention.
enterologist. Patients were eligible for the study if they met
the following inclusion criteria: (1) age 18 years or older; (2) IBS Severity Scoring System (IBS-SSS)
English-speaking; and (3) had a diagnosis of IBS confirmed
by a gastroenterologist using the standard Rome III criteria The severity scoring system (SSS) is an IBS-specific instru-
[13]. Exclusion criteria for this study included: (1) a con- ment that is sensitive to change in symptoms over time [34].
current self-reported diagnosis of a DSM-IV axis I mood, The score of the system is based on five items and uses
anxiety, or psychotic disorder; (2) current use of antipsy- visual analogue scales. The symptom severity score was
chotics; or (3) past participation in an MBSR group. calculated by summing the five items: pain severity, pain
Medical or psychiatric conditions and medications were frequency, distension, bowel habit dissatisfaction, and life
388 Int.J. Behav. Med. (2013) 20:385396

interference. Patients were classified as having either mild period of 20 days on average. This was consistent with the
IBS (75174), moderate IBS (175299), or severe IBS POMS as a measure of mood states, which were expected to
(300500). Scores below 75 indicate remission or normal vary over time (nonstable traits), and supported its construct
bowel function. This measure has adequate discriminant validity [37].
validity between controls and patients diagnosed with IBS
(p00.0001), as well as between the severity categories mea- Symptoms of Stress (C-SOSI)
sured (p<0.01) [34]. In a validation paper to test respon-
siveness, Francis et al. [34] measured scores of IBS patients A short form of the Symptoms of Stress Inventory (SOSI)
both before and after a psychosocial intervention designed [38], the Calgary Symptoms of Stress Inventory (C-SOSI)
to treat IBS symptoms. Patients judged independently by a [39], was used to measure physical, psychological, and
clinician as considerably better after the intervention behavioral responses to stressful situations. The question-
showed a change score of 50 points, reliably indicating naire consists of 56 items and 8 subscales. The C-SOSI has
clinical improvement. The instrument has high reproducibility good internal consistency and face validity. Cronbachs
for scores repeated within 24 h and is sensitive to change reliabilities for the subscales ranged from 0.80 to 0.95 [39].
(p<0.001). In this study a change of 50 points was similarly
considered clinically meaningful. Spirituality (FACIT-sp)

Secondary Outcome Measures Spiritual well-being was measured using the Functional
Assessment of Chronic Illness TherapySpiritual Well-
Quality of Life (IBS-QOL) being (FACIT-sp) Scale [40], a 12-item self-report question-
naire designed for people with chronic illnesses which
The IBS-QOL measurement is a 34-item instrument devel- measures a sense of peace and meaning and purpose in life.
oped at the University of Washington [35]. The measure is In a study of 1,617 subjects with chronic illness (83.1 %
scored using a five-point Likert scale with scores summed were patients with cancer), internal consistency was 0.87 for
on eight subscales. These subscales are labeled dysphoria, the total FACIT-sp score. Reliability was also shown in this
interference with activity, body image, health worry, food multiethnic sample [40]. This instrument was included
avoidance, social reaction, sexual, and relationships. Signif- because it has been shown to increase in previous MBSR
icant correlations were shown between change scores on the studies in other medical populations [41].
IBS-QOL and other measures of treatment effect (i.e.,
averaged daily pain/14 days, Sickness Impact Profile total Intervention
score, and Sickness Impact Profile psychosocial score)
[36]. The IBS-QOL measure demonstrated high internal The MBSR intervention was based on the program designed
consistency (Cronbachs 00.95) and high reproducibility by Kabat-Zinn and colleagues at the Stress Reduction Clinic
(ICC00.86) with average time of 7 days (SD01). Regarding at the University of Massachusetts Medical Center [27] and
discriminant validity, number of symptoms (p<0.05), self- detailed elsewhere [4144]. All sessions were administered
reported severity of symptoms (p<0.001), and functional by a registered nurse who was also a certified yoga instruc-
bowel disorder severity index (p<0.001) predicted IBS-QOL tor and professionally trained through the University of
scores [35]. Convergent validity confirmed predictions that Massachusetts Medical Center Oasis MBSR training pro-
scores were more closely related to psychological well-being gram. She has been teaching MBSR since 2000 and facili-
(0.45) than to function (0.36) on this scale [35]. tated numerous trials ongoing at the Tom Baker Cancer
Centre, Calgary, Canada. This manualized group interven-
Mood (POMS) tion consisted of eight weekly group sessions 90 min in
duration, in addition to a 3-h morning workshop retreat
Current mood was measured with the Profile of Mood States between weeks 6 and 7. Shorter classes and retreat com-
(POMS) [37]. This instrument generates scores on six pared to the standard protocol were used for logistical rea-
dimensions of mood: tensionanxiety, depressiondejection, sons of integrating the research protocol into the ongoing
angerhostility, vigor, fatigue, and confusion. It has been clinical and research programs at the Tom Baker Cancer
widely used in psychiatric and medical populations. The Centre. Patients were taught meditation techniques and body
POMS measures state (vs. trait) attributes, which makes it awareness skills in a didactic classroom format and were
appropriate for repeated measures. KuderRichardson inter- encouraged to engage in home practice of meditation and
nal consistency of the six subscales ranged from 0.84 yoga between class sessions. Instructional and experiential
(confusion) to 0.95 (depression) in two studies, with test modes of learning were used to implement the intervention.
retest stability of 0.65 (vigor) to 0.74 (depression) over a General psychoeducation regarding stress and the stress
Int.J. Behav. Med. (2013) 20:385396 389

response was taught. The 3-h retreat allows for an extended patients who provided baseline data were included in the
practice of a combination of mindfulness skills learned in analyses. Post hoc comparisons were conducted to follow-
the program including yoga, sitting meditation, body scan, up significant main effects and interactions. Linear mixed
lovingkindness meditation, and walking meditation. The models is an appropriate statistical method for longitudinal
retreat was conducted in silence for patients and encouraged designs with missing data in clinical trials as it imputes
further delving into the mindfulness practice with an extended missing data using mathematical models rather than relying
period of time for inner reflection and the development of on last observation carried forward. A completers analysis
insight. was also conducted to compare the ITT linear mixed model
At the start of the MBSR program, each patient was results to the data provided by patients who completed five
provided a 52-page booklet and two CDs to aid in home or more classes (more than half the program) due to the
meditation and yoga practice. To measure adherence, the significant dropout rates. The completers analysis is
MBSR instructor recorded the number of classes each reported if it differed from the primary ITT analysis in the
participant attended, and the patients recorded the total Results section below. All data analyses were carried out
minutes spent daily mediating and practicing yoga on a using SAS for Windows version 9.2 (SAS Institute Inc.,
weekly practice log included in the booklet during the 2008). Additional analyses were calculated for the IBS-SSS
course of the intervention. All practice logs were collected scale, including IBS symptom severity change scores for
weekly by the instructor during the intervention. While logs patients who completed the program to compare results to
collected by the instructor may introduce a social desirability previously published research, as well as an analysis of
bias, this action was taken to attempt to mitigate the issue of clinical response defined and calculated as the number of
patients attempting to retrospectively, at the end of the 8-week patients who showed a 50-point improvement on the
intervention, complete several weeks of logs and report the IBS-SSS.
minutes/activities they had completed several weeks ago. The
instructor did not look at or comment on the logs as they were
simply put into an envelope each week which went directly to Results
the researcherpatients were aware of this setup, told that it
was done so that they would not feel any pressure, and asked Participant Characteristics
to be honest with their logs for the sake of the study. All
patients were encouraged in both the treatment and control Screening, eligibility, consent, and dropout rates are provided
conditions to continue with their general medical care and (Fig. 1). One hundred and five eligible patients were assessed.
IBS-specific care throughout the study, such as attending In total, 90 patients completed baseline measures and were
regularly scheduled appointments with their specific gastro- then randomized into treatment conditions (immediate n043,
enterologist, and to continue with any of their medications and wait-list n047). Four cohorts were conducted, and within each
treatments throughout the study. class, there was a range of 1119 patients. The majority of
patients were women (90 %) and in a coupled relationship
Data Analysis (62.2 %). Patients ranged in age from 18 to 77 years with a
mean age of 45 years (Table 1).
Power analyses were conducted for the current trial using
the IBS-SSS validation paper of Francis et al. [34]. Allow- Attrition and Compliance
ing for 20 % attrition, 42 patients per group (n084) were
required to detect a magnitude of change at 00.80 and Dropout rates for intervention and control groups did not
00.05. All data provided by patients were included in the differ significantly, 2(1,90) 02.03, p 00.15. Of the 43
analyses. Data were tested for normality and homogeneity MBSR patients, 24 completed at least 5 or more classes,
of variance. To verify that the intervention and control and of the 47 patients waiting, 36 completed the waiting
groups were comparable on continuous and categorical period and second questionnaire (Fig. 1). The mean number
demographic variables, IBS symptom severity, and psycho- of MBSR classes attended was six out of nine (including the
logical variables at pre-intervention, a series of independent half-day silent retreat). The mean amount of home medita-
samples t tests and chi-squared tests were conducted. If tion and yoga practice, which did not include the weekly
between-group differences existed at baseline, such differ- class practice or retreat, was 137 min/week. No significant
ences were adjusted for statistically in subsequent analyses. differences were found between those who completed and
In order to evaluate the impact of the MBSR intervention those who did not complete the study in terms of the
on the primary and secondary outcome measures, linear measured continuous or categorical demographic variables
mixed models for repeated-measures analyses were per- or baseline IBS symptom severity, QOL, mood, stress, or
formed using an intent-to-treat (ITT) principle, so that all spirituality scores. All MBSR and control group baseline,
390 Int.J. Behav. Med. (2013) 20:385396

Fig. 1 Flowchart
Interested and assessed for eligibility (n=105)

Ineligible/Refused (n=15)
14-Did not consent 86%
1-Ineligible accrued

Randomized (n=90)

Assigned to TAU wait-list Assigned to Mindfulness-

control Based Stress Reduction
(n=47) (n=43)

Non-Completers (n=19)
4-Classes attended=0
Non-Completers (n=11) 15-Classes attended = between 1-4
5-Too busy
Attrition 10-No reason given
2-Unavailable 3-Scheduling issues Attrition
= 23% 2-No reason given 2-Not interested = 44%
1-Did not want to wait
1-No transportation
1-Surgery 1-Too busy
1-Out of country
1-Moving

Post 8-week Wait (n=36) Post 8-week Program (n=24)

2-lost to follow up 4-Lost to follow up

Attrition Attrition
= 6% = 17%

6-Month Follow-up (n=34) 6-Month Follow-up (n=20)

Analyzed Analyzed
Completers Analysis (n=36) Completers Analysis (n=24)
ITT (n=47) ITT (n=43)

8-week, and 6-month means and standard deviations for all completed 5 or more classes, 10 had a clinically significant
scales are presented in Table 2. improvement in symptoms (50 %) post intervention.
For the 47 TAU wait-list group patients that completed
IBS Symptom Severity (IBS-SSS) the IBS-SSS, 10 out of 47 patients (21 %) had a clinically
significant improvement in IBS symptoms. Although the
Results of the linear mixed model analyses of IBS symptom wait-list did not show improvements in symptom severity
severity total scores revealed a time by group interaction, from baseline to 8-week assessment, symptoms were signif-
F(2,106)03.90, p00.02, which indicated that the group icantly reduced from baseline to 6-month follow-up;
effect varied with time and vice versa. Testing of simple however, this symptom reduction did not meet clinical sig-
effects indicated that IBS symptom severity improved nificance. The MBSR treatment group reported lower symp-
(p<0.0001) from pre- to post-intervention for the immediate tom severity overall at post-intervention compared to the
MBSR group, with results maintained at 6-month follow-up wait-list group. There was no difference between the two
(p00.17). This improvement was clinically meaningful with groups at 6-month follow-up (Fig. 2).
an overall change score >50 points. Of the 24 patients that Change scores calculated for patients who completed the
completed 5 or more classes, 4 of these patients did not intervention showed a 30.7 % reduction in IBS symptom
complete the post-MBSR intervention (T2) IBS-SSS ques- severity immediately post-MBSR compared to the controls
tionnaire. Therefore, out of 20 patients with full data who (5.2 %). The ITT estimate using linear mixed models for
Int.J. Behav. Med. (2013) 20:385396 391

Table 1 Participant demographics 6-month follow-up. The treatment group reported fewer
Mindfulness group Wait-list group overall symptoms of stress at post-intervention relative to
(n043) (n047) the wait-list group. The groups did not differ at 6-month
follow-up (Fig. 3).
Sex
Female 40 (90.3 %) 41 (87.2 %)
Profile of Mood States (POMS)
Male 3 (7.0 %) 6 (12.8 %)
Age 45 (SD012.4) 44 (SD012.6)
Linear mixed model analyses revealed a main effect of time
Relationship status
on patients total mood disturbance scores, F(2,109)08.48,
Singlenever married 14 (32.6 %) 12 (25.5 %)
p<0.001. Post hoc analyses indicated that mood scores at 8-
Living with partnernever 1 (2.3 %) 5 (10.6 %) week assessment and at 6-month follow-up were lower
married
Married 22 (51.2 %) 28 (59.6 %) compared to baseline mood scores regardless of group
Divorced or separated 4 (9.3 %) 2 (4.3 %) assignment.
Widowed 1 (2.3 %)
Not disclosed 1 (2.3 %) Quality of Life (IBS-QOL)
Employment status
Full-time 24 (55.8 %) 31 (66.0 %) Results of the linear mixed model analyses on the IBS-QOL
Part-time 9 (20.9 %) 7 (14.9 %) total scores revealed main effects of time, F(2,109)09.62,
Unemployed 4 (9.3 %) 5 (10.6 %) p < 0.001. Results of follow-up analyses indicated that,
Retired 4 (9.3 %) 2 (4.3 %) regardless of group assignment, total scores for QOL
Disability 2 (4.3 %) improved at 8-week and 6-month assessment compared to
Not disclosed 2 (4.7 %) baseline scores.
Education
Primary/secondary school 1 (2.1 %) Spirituality (FACIT-sp)
High school graduate 4 (9.3 %) 8 (17.0 %)
Some university/college/tech 9 (20.9 %) 12 (25.5 %) A main effect of time was observed for the FACIT-sp total
College/tech degree 11 (25.6 %) 9 (19.1 %) score, F(2,106)04.96, p00.009. Post hoc analyses revealed
University degree 11 (25.6 %) 13 (27.7 %) higher total scores at 8-week assessment and at 6-month
Masters/postgraduate degree 5 (11.6 %) 3 (6.4 %) follow-up when compared to the baseline, regardless of
Doctoral degree 1 (2.3 %) 1 (2.1 %) group assignment.
Not disclosed 2 (4.7 %)

Discussion

repeated measures (included all patients who provided baseline The primary aim of this study was to evaluate the impact of
scores) showed a 16.9 % reduction in IBS symptom severity an 8-week MBSR program on the physical symptoms of
post-MBSR compared to 3.5 % in the controls. IBS in men and women. Consistent with our primary
hypothesis, the MBSR treatment group improved more than
Symptoms of Stress (C-SOSI) the controls on the primary outcome of symptom severity.
The change was clinically meaningful and brought symp-
Analyses of the C-SOSI total scores revealed a time by toms from the severe to moderate range. These improve-
group interaction, F(2,108)03.92, p00.02, which indicated ments were maintained over 6 months. Practically, this
that the group effect varied with time and vice versa. Testing would mean a person went from almost constantly having
of simple effects indicated that symptoms of stress were severe and frequently interfering symptoms of pain and/or
reduced (p<0.0001) from pre- to post-intervention for the bowel distension and low satisfaction with their bowel habit
MBSR treatment group, with results maintained at 6-month in general to only occasionally experiencing these problems.
follow-up (p00.08). However, for patients who completed Such a change could conceivably mean the difference
five or more classes, from post-MBSR to 6-month follow- between remaining cloistered in the home to being able to
up, there was a significant rebound effect (p00.04). The participate more in work and social functions. These
wait-list group did not show a reduction in symptoms of improvements occurred despite the intervention being a
stress from baseline to 8-week assessment; however, stress fairly generic MBSR program. An MBSR program
symptoms were significantly reduced from baseline to adapted and more specifically geared toward IBS-specific
392 Int.J. Behav. Med. (2013) 20:385396

Table 2 Means and standard

errors and effect sizes for out- Mindfulness group, adjusted Wait-list group, adjusted Cohens d
come measure total scores for mean (SD) (n043) mean (SD) (n047) (between groups)
MBSR treatment and control
groups IBS-SSS total scorea,b,*,**
Baseline 248.6 (108.9) 249.0 (107.6)
Posttreatment 169.4 (125.9) 230.0 (117.9) 0.50
6-month follow-up 193.6 (128.5) 213.8 (119.3) 0.16
IBS-QOL total scoreb,**
Baseline 65.3 (23.6) 61.6 (23.3)
Posttreatment 75.0 (24.9) 63.1 (23.3) 0.49
6-month follow-up 74.3 (26.9) 66.5 (24.0) 0.31
a,b ,
C-SOSI total score * **
Baseline 76.7 (34.8) 81.7 (34.3)
Posttreatment 52.2 (40.7) 75.7 (37.7) 0.60
6-month follow-up 62.1 (41.3) 69.8 (38.4) 0.19
POMS total scoreb,**
Baseline 48.6 (36.7) 50.1 (36.3)
Posttreatment 28.5 (45.9) 37.4 (41.8) 0.21
6-month follow-up 31.6 (47.2) 33.5 (42.5) 0.04
FACIT total scoreb,**
Baseline 27.5 (8.5) 25.9 (8.9)
*p<0.05; **p<0.01
a
Posttreatment 30.5 (10.5) 26.8 (9.6) 0.37
Interaction effect
b
6-month follow-up 30.4 (10.5) 28.3 (9.6) 0.21
Time effect

content may yield greater improvements in IBS symptoms; 26.4 % reduction on the same scale, compared to 6.2 % for
however, this has yet to be evaluated. the support group condition [32]. Our more conservative
Compared to the only other randomized trial of MBSR ITT estimate, which included all patients who completed
for IBS patients [32], these results are similar. Patients who baseline data in the analysis, showed a 16.9 % reduction in
completed the intervention in our study had a 30.7 % reduc- IBS symptom severity post-MBSR compared to 3.5 % in the
tion in IBS symptom severity immediately post-MBSR controls. The actual impact of the program likely lies
compared to the controls (5.2 %). Gaylord et al. showed a between these two values.

Fig. 2 Impact of MBSR on the

IBS-SSS. The line graph repre-
sents the association between
group status (treatment vs. con-
trol) and change in total IBS
severity scores across three time
periods
Int.J. Behav. Med. (2013) 20:385396 393

Fig. 3 Impact of MBSR on the

C-SOSI total score. The line
graph represents the association
between group status (treatment
vs. control) and change in total
symptoms of stress scores
across three time periods

Where our methods differed from Gaylord et al. [32] is in Similar to the previously reported results of IBS symptoms,
following up patients for twice as long post-program and overall symptoms of stress also continued to improve slowly
including a wider range of outcome measures across many over time.
domains. Interestingly, we saw something of a rebound While there were specific improvements in IBS and
effect of symptoms in the MBSR group over the follow-up stress symptoms in the MBSR group, both groups improved
period (Fig. 2), while the control patients continued to over time on IBS-specific QOL, mood disturbance, and
improve slowly over time. This suggests that the acute spirituality. A possible explanation for this is similar to that
effects of program participation far outstrip the rate of for specific IBS symptoms, that improvements may be due
improvement in the absence of intervention, but this rate to nonspecific effects. Symptom monitoring, attention from
of improvement is not necessarily sustained over time. the research team, and anticipation of a treatment program
Unfortunately, attempts to collect data on adherence to could lead to appreciable symptomatic relief among control
meditation practice over the follow-up period were not group patients, while attention and group support could be
successful and we were unable to assess any associations beneficial to those in the treatment group. Consistent with
between further changes and home practice. One might this interpretation, patients diagnosed with IBS respond well
assume that those patients who continued to practice to placebo in drug studies, where up to 72 % of those in a
meditation over time may maintain the initial program placebo condition experience symptom improvement as
benefits, but we were unable to assess this question. measured by global symptom ratings [50]. A second possible
It might also seem surprising that the control group was explanation for overall improvement is that the process of
improving slowly over time on IBS-specific measures, filling out questionnaires leads patients to reflect upon their
given the chronic nature of the illness and long time since current thoughts, symptoms, feelings, and behaviors.
symptom onset (>1 year). One possible explanation for this Self-monitoring is a treatment component of cognitive behav-
may be positive expectations about starting the MBSR ioral therapy for IBS, but the incremental effect of symptom
program after the waiting period. Follow-up by the research monitoring in a multicomponent treatment has yet to be
team and continued self-monitoring and support over this evaluated.
period may have also contributed to this improvement. This study had several strengths and limitations. A
This trial was the first to specifically measure symptoms significant strength was the randomization of patients to
of stress in MBSR for IBS patients. As predicted, MBSR either the MBSR or TAU wait-list condition and the extended
patients had decreased overall symptoms of stress compared 6-month follow-up. The recruitment and randomization pro-
to the controls immediately after the 8-week program. These cess resulted in two groups that were equivalent at baseline on
results are consistent with MBSR outcomes in a variety of demographics and pre-intervention test scores. A second
other clinical populations such as anxiety, fibromyalgia, significant strength of our study is the data analytic procedure
cancer, and hypertension [28, 41, 4549]. For the first time, which accounts for our high attrition rate. While there were no
this can now be extended to an IBS-specific population. significant differences in attrition between the MBSR and
394 Int.J. Behav. Med. (2013) 20:385396

control conditions, a substantial number of patients did not research that indicates that a proportion of IBS sufferers
complete the full trial, with 44 % in the MBSR group not seeking health care are unwilling to consider stress as an
completing five or more classes. The time commitment and operative factor in IBS [36, 51, 52]. We also encountered
motivation required to attend a class for 8 weeks for 1.5 hours, this opinion in many of the IBS patients who were called for
plus 45 min of meditation and yoga daily were significant. the study but were not interested in participating.
This group of patients was recruited largely by cold calling In summary, participation in the MBSR program was
patients from gastroenterologists charts; hence, many had associated with a significant reduction in IBS symptom
been diagnosed many months or years previously, and none severity and symptoms of stress, compared to the TAU
were specifically symptomatic or seeking treatment options wait-list control condition. Improvements in IBS-related
for stress reduction. Hence, they may not have been highly QOL and mood were observed for both the intervention
motivated to complete treatment if they became busier than and TAU wait-list. As many studies have linked high symp-
anticipated, had significant stressors arise, or did not immediately toms of stress, mood disturbance, and low QOL to adverse
see the value of the intervention. health outcomes, the current and previous studies suggest
The current studys results should be considered within that mindfulness meditation may be an activity that pro-
the methodological limitations of a preliminary treatment motes better health. Overall, MBSR is a promising psycho-
outcome study with a relatively small sample, including the social intervention for patients suffering with the symptoms
fact that the control group did not receive any placebo of IBS and further randomized controlled trials with active
intervention which would be considered the gold standard control conditions and longer-term follow-up are needed to
for randomized intervention trials. However, a meta-analysis determine the effect of such a program for this heteroge-
conducted by Grossman et al. revealed similar effect sizes neous patient population.
across many types of MBSR study designs (e.g., controlled
vs. observational) and within the controlled study analysis Acknowledgments Dr. Linda E. Carlson holds the Enbridge
(active control vs. wait-list), which provide support for the Research Chair in Psychosocial Oncology, co-funded by the Alberta
specificity of the mindfulness intervention [30]. Cancer Foundation and the Canadian Cancer Society Alberta/NWT
Division. She is also an Alberta Heritage Foundation for Medical
Patients with self-reported axis I mood and anxiety Research Health Scholar. This research was supported by a Calgary
disorders were excluded in order to produce a clean sample; Health Region/Centre for the Advancement of Health Research Grant
however, due to the relatively high comorbidity rates of awarded to Dr. Carlson. Kristin Zernicke holds a Canadian Institute of
mood and anxiety disorders within the IBS population, this Health ResearchFrederick Banting and Charles Best Canada
Graduate Scholarship, an Alberta InnovatesHealth Solutions
limits the generalizability of our sample. While we did not Studentship, and a Psychosocial Oncology Research Training Fellow-
conduct standardized diagnostic interviews to assess such ship. We would like to thank our dedicated MBSR instructors, research
comorbidities, we asked patients to self-report comorbid assistants, and the patients who participated in this research. Without
disorder diagnoses and also screened patients medical them, this research would not be possible.
charts for comorbid diagnostic information. Another limit Conflict of interest None.
to generalizability is that over half of the treatment and
control groups earned a post-secondary degree within our
sample, as well as in the trial of Gaylord et al. [32]. Hence,
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